NEW YORK, Oct. 18 - Genaissance Pharmaceuticals has launched a second version of its STRENGTH study after one drug from the original trial was taken off from the market after it was linked to patient deaths, the company said on Thursday.
The new study, called STRENGTH II, will investigate just one drug and will complement the current and ongoing STRENGTH trial that is testing four commonly prescribed cholesterol-lowering drugs to detect genetic differences responsible for the wide range of responses they elicit, according to Genaissance.
Both studies, which are similar to phase II clinical trials, are trying to uncover how 1,500 haplotypes on roughly 100 genes from a variety of pathways influence the way patients respond to the four drugs. Results for STRENGTH and STRENGTH II are expected in the first quarter and third quarter 2002, respectively, according to New Haven, Conn.-based Genaissance.
As GenomeWeb reported , STRENGTH, or Statin Response Examined by Genetic HAP markers, was launched in April and involved four antihypercholesterolemia drugs: Zocor, known generically as simvastatin; Lipitor, also known as atorvastatin; Pravachol, or pravastatin; and Baycol, also called cerivastatin. Baycol, made by German drug and chemical giant Bayer, was withdrawn from the market in August.
Each drug is currently being tested at more than 150 patients with hypercholesterolemia at 60 centers around the country. Since Baycol was withdrawn before the study was completed, Genaissance decided to begin a new study to fill its slot. The new drug, Mevacor, will be studied in 150 volunteers at 45 centers nationwide, Genaissance said.
According to Oestreicher, the original four drugs were chosen because they were “the most heavily supported and marketed.” The reason not to include Mevacor initially was that it is going off patent soon, he said. But proving that it works better in a genetic subset of people might open new avenues. “This might be a strategy to use off-patent products,” Oestreicher said.